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HYPITAT-II Hypertension and Pre-eclampsia Intervention Trial At near Term Go to the Hypitat II website
Study population Inclusion criteria
¡¤ Maternal age ¡Ý 18 years ¡¤ Pregnancy induced hypertension o 100 mmHg ¡Ü diastolic blood pressure ¡Ü 110 mmHg, without medication at two occasions at least six hours apart o Patients who after stabilization of the high blood pressure (diastolic blood pressure > 110 mmHg) with oral or i.v. medication reach a stable diastolic blood pressure RR ¡Ü 110 mmHg. ¡¤ Preeclampsia o diastolic blood pressure ¡Ý 90 mmHg at two occasions at least six hours apart o o Eiwit Kreatinine Ratio (EKR) > 30 ¡¤ Chronic hypertension o with superimposed preeclampsia (with proteinuria as defined above) or o the need for additional anti-hypertensive medication started after 34 weeks (i.e. another drug than that was used before) ¡¤ Gestational age between 34+0 and 37+0 weeks ¡¤ Exclusion criteria Diastolic blood pressure ¡Ý 110 mmHg despite medication Systolic blood pressure ¡Ý 170 mmHg despite medication Renal disease Heart disease Seropositive for HIV Haemolysis Elevated Liver enzymes Low Platelets (HELLP) syndrome Pulmonary edema or cyanosis Proteinuria ¡Ý 5 g/L Oliguria < 500 mL in 24 hours Non-reassuring foetal heart rate, O-flow or reverse flow Severe foetal abnormalities including abnormal karyotype. Severe preeclamptic complaints, such as frontal headache No reason for exclusion are: Women with multiple pregnancy Women with a child in breech presentation. (Patients can be counselled for a vaginal breech delivery or a caesarean section). Women with a caesarean section in previous pregnancy. (Patients can be counselled for an induction of the delivery or a caesarean section. The use of prostaglandins are contraindicated. Induction should be performed by rupture of membranes or a Foley-catheter.) Diabetes Fetal Growth Restriction, though good fetal condition.
Outcome measures
The maternal primary outcome measure will be a composite endpoint of maternal mortality, maternal complications (eclampsia, HELLP syndrome, pulmonary edema) and progression to severe pre-eclampsia. The neonatal primary outcome measure will be respiratory distress syndrome (RDS), which can be complicated by fetal mortality in rare cases. Secondary outcome measures Secondary maternal outcomes will be caesarean section rate, instrumental vaginal delivery rate, maternal quality of life and quality of recovery and costs. Secondary neonatal outcome will be neonatal morbidity defined as neonatal infection or sepsis, intravenous therapy needed hypoglycaemia, wet lung syndrome, meconium aspiration syndrome, pneumothorax and/or pneumomediastinum, periventricular leucomalacia, convulsions and other neurological abnormalities necrotising enterocolitis (NEC), intraventricular haemorrhage (IVH) or asphyxia. Adverse neonatal outcome will be defined as a 5-minute Apgar score below 7, an umbilical artery pH below 7.05 or admission to the neonatal intensive care.
Project leaders Dr. B.W. Mol, gynecologist, Dr. M.G. van Pampus, gynecologist, OLVG Amsterdam
Health Technology Assessment Methodology
Contact Drs. K. Broekhuijsen Dept. Obstetrics/Gynecology T: +31 6 16972879 |